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临床试验/NCT04437849
NCT04437849已完成不适用

Trial Clínico: Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad

Universidad Nacional de Tucuman2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

研究概览

简要总结

This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves quality of life and HF related-knowledge. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • were over 18 years with a primary diagnosis of HF,
  • had been hospitalized at least once time as a consequence of a HF decompensation,
  • had a Smartphone,
  • had access to WiFi,
  • had access to a weight scale and to a blood-pressure monitor

排除标准

  • illiterate patients,
  • had learning difficulties,
  • had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.

结局指标

主要结局

Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

时间窗: 3-month

Changes in HF related knowledge through the Knowledge of CHF questionnaire

时间窗: 3-month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucía María Yanicelli

Principal Investigator PhD in Exact Sciences and Engineering

Universidad Nacional de Tucuman

研究点 (2)

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